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PHASE III TRIAL INVESTIGATING BENEFIT OF INTENSIFIED PERI-OPERATIVE CHEMOTHERAPY WITHIN HIGH-RISK CINSARC PATIENTS WITH RESECTABLE SOFT-TISSUE SARCOMAS
EU CTIS ID: 2023-509489-39-00
What this study is testing
The primary objective of this trial is to investigate whether the addition of 3 additional neo-adjuvant cycles of chemotherapy (doxorubicin based chemotherapy) to standard management according to the ISG-STS 10-01 study (3 cycles of neoadjuvant doxorubicin based chemotherapy + surgery +/- radiotherapy) improves the outcome of high-risk CINSARC patients with resectable soft-tissue sarcoma (STS). Primary endpoint is metastatic progression-free survival (M-PFS, after 3 years of follow-up).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically confirmed soft-tissue sarcoma by the RRePS (Réseau de Référence en Pathologie des Sarcomes et des Viscères) network, as recommended by the French NCI,
- Women of childbearing potential must have a negative serum pregnancy test before study entry. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for one year after discontinuation of treatment. Acceptable methods of contraception include intrauterine device (IUD), oral contraceptive, subdermal implant and double barrier. Subjects of childbearing potential are those who have not been surgically sterilized (e.g., vasectomy for males and hysterectomy for females) or have not been free from menses for ≥ 1 year,
- Voluntarily signed and dated written informed consents prior to any study specific procedure,
- Patients with a social security in compliance with the French law.
- Grade 2 or 3 according to the FNCLCC grading system,
- Available archived tumour sample for research purpose,
You likely can't join if
- Soft-tissue sarcoma with the following histological subtypes: well-differentiated liposarcoma, alveolar soft-part sarcoma, dermatofibrosarcoma protuberans, clear-cell sarcoma, embryonal and alveolar rhabdomyosarcoma,
- Prior or concurrent malignant disease diagnosed or treated in the last 2 years except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma, or in situ transitional bladder cell carcinoma,
- Any other contraindication to anthracycline, ifosfamide or dacarbazine,
- Participation to a study involving a medical or therapeutic intervention in the last 28 days,
- Known infection with HIV, hepatitis B, or hepatitis C,
- Females who are pregnant or breast-feeding,
See the full eligibility criteria
- Histologically confirmed soft-tissue sarcoma by the RRePS (Réseau de Référence en Pathologie des Sarcomes et des Viscères) network, as recommended by the French NCI,
- Women of childbearing potential must have a negative serum pregnancy test before study entry. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for one year after discontinuation of treatment. Acceptable methods of contraception include intrauterine device (IUD), oral contraceptive, subdermal implant and double barrier. Subjects of childbearing potential are those who have not been surgically sterilized (e.g., vasectomy for males and hysterectomy for females) or have not been free from menses for ≥ 1 year,
- Voluntarily signed and dated written informed consents prior to any study specific procedure,
- Patients with a social security in compliance with the French law.
- Grade 2 or 3 according to the FNCLCC grading system,
- Available archived tumour sample for research purpose,
- Non-metastatic and resectable disease,
- No prior treatment for the disease under study,
- Age ≥ 18 years,
- Life expectancy ≥ 3 months,
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1,
- Patients must have measurable disease (lesion in previously irradiated field can be considered as measurable if progressive at inclusion according to RECIST 1.1) defined as per RECIST v1.1 with at least one lesion that can be measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm or ≥ 15mm in case of adenopathy,
- Soft-tissue sarcoma with the following histological subtypes: well-differentiated liposarcoma, alveolar soft-part sarcoma, dermatofibrosarcoma protuberans, clear-cell sarcoma, embryonal and alveolar rhabdomyosarcoma,
- Prior or concurrent malignant disease diagnosed or treated in the last 2 years except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma, or in situ transitional bladder cell carcinoma,
- Any other contraindication to anthracycline, ifosfamide or dacarbazine,
- Participation to a study involving a medical or therapeutic intervention in the last 28 days,
- Known infection with HIV, hepatitis B, or hepatitis C,
- Females who are pregnant or breast-feeding,
- Other medical conditions may interfere with the conduct of the study and, in the judgment of the investigator, would make the patient inappropriate for entry into this study,
- Individuals deprived of liberty or placed under legal guardianship,
- Unwillingness or inability to comply with the study protocol for any reason.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.